Solid state chemistry is fundamental to the development of a pharmaceutical compound into a drug product, and understanding analytics is crucial to successfully addressing any challenges that can occur in a product’s lifecycle. In solid state chemistry specifically, the physical and chemical (PhysChem) analytics will show which properties need to be improved to help ensure the highest chances of success: purity, stability, solubility, or bioavailability.
In drug development, knowing the characteristics of each form of the active pharmaceutical ingredient (API) is essential in order to select the most suitable form for production. For the research chemist, the PhysChem purity is one of the most crucial requirements. Furthermore, selection of the thermodynamically most stable polymorph; low hygroscopicity measured by dynamic vapor sorption (DVS); consistent crystallinity measured using X-ray powder diffraction (XRPD); sharp single melting event determined by differential scanning calorimetry (DSC); and low levels of residual solvent by thermogravimetric analysis (TGA) are all part of the ranking criteria. Aqueous solubility and dissolution rate are indispensable for the route of delivery and dosage form.